Good News| CTCBIOPSY 4 Products Certified by CE-IVDR
Recently, self-developed 4 CTCBIOPSY® products obtained CE certificates.CTCBIOPSY is an automated circulating tumor cell (CTC) separator instrument, through the use of polymer materials made of microporous filtration device, based on the CTCs size, deformation capacity, fluid mechanics and other physical characteristics of differences. The circulating tumor cells in peripheral blood can be separated and enriched from blood cells quickly and accurately. The cell morphology of CTC and CTM can be observed under ordinary optical microscope by combining with Wright-Giemsa staining kit.
By detecting the quantity of CTCs and CTM in peripheral blood of patients, it can help clinicians evaluate the progress of tumor patients and guide follow-up diagnosis and therapies as soon as possible.
CE certificate means that these products can be available in Europe and other regions that accept the EU certification. This not only greatly expands the market coverage of the company's products, but also provides a strong support for further expanding the overseas customer base. YZY MED, as an in vitro diagnostic medical company that meets strict safety standards and quality requirements, this certification will provide greater confidence and guarantee for the company's customers at home and abroad.
About YZY MED
Founded in 2011, with personalized diagnosis and treatment of cardiovascular, tumor as the strategic direction, Wuhan YZY Medical Science and Technology Co., Ltd. (YZY Med)is a high-tech enterprise specializing in R&D, production and sales of individualized medical diagnostic products. The company has established various technical platforms, including ARMS fluorescence quantitative PCR, multiple fluorescence quantitative PCR,fluorescence in situ hybridization(FISH) and circulating tumor cell(CTC) detection, etc. Meanwhile, the selfdeveloped products include molecular diagnostic products to guide personalized medicine for cardiovascular and cerebrovascular diseases,companion diagnostic products to guide tumor diagnosis and treatment, FISH products and circulating tumor cell (CTC) Autoanalyzer System, all these provide clinical diagnosis basis for precision medicine.
The company has successfully developed over 160 genetic diagnostic products and multiple in vitro diagnostic (IVD) devices, among which 16 molecular diagnostic kits have been approved by the NMPA Class III medical device registration and approval, more than 110 products have obtained CE certification by the European Union.